Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for a Manager of Pharmacovigilance (PV) Compliance Operations to be based in Horsham, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.  

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The Manager, PV Compliance Operations is responsible for oversight of investigation processes associated with delays in the receipt and/or in the management of adverse event or safety information. This may include the compliance investigation processes associated with late Individual Case Safety Reports (ICSRs) submissions to Health Authorities or delays in receipt of safety information from Janssen business partners or Janssen Local Operating Companies.  The individual will also be responsible for responses from Janssen to Alliance Partners when compliance documentation is requested from Janssen.  Monitors case receipt compliance investigations of safety information associated with Local Operating Companies, ensures that they are completed within SOP timelines and that appropriate documentation is completed and retained. This person may be responsible for direct or indirect oversight of J&J employees and vendor resources.

• Performs and/or manages complex compliance investigations related to Local Operating Companies, Vendors and Alliance Partners and other complex investigations within Drug Safety as needed
• Driving accuracy and consistency of compliance investigations and investigation categorizations
• Provides input into corrective/preventative actions and effectiveness measures for CAPAs as appropriate
• Collecting and analyzing compliance results, and sharing results with Janssen management, Alliance Partners and vendor compliance contacts
• Works across functional areas to develop and implement strategies to drive compliance improvements. 
• Keys for success in this role include the ability to develop collaborative partnerships with Alliance Partner and Local Operating Company colleagues of all levels and to influence without authority when complex issues or negotiations arise
• Must have the ability to resolve complex issues independently and to determine when escalation to senior management is appropriate.
• Ensuring quality of all documentation, driving process improvements and tracking, trending and presenting trends of late submission root causes
• Provides input into corrective/preventative actions and effectiveness measures for late ICSR and Aggregate Report CAPAs and other compliance related CAPAs as appropriate
• Works closely with Associate Director, Compliance Operations to implement strategies for compliance improvements
• Interfaces directly with all functions impacting GMO / GMS monitored compliance metrics (including but not limited to): Case Management; Case Reporting; Vendor Compliance Points of Contact; PAC; IPV / LSO; LOC; QPPV; 3rd Party Compliance Contact; GRA; GCO

Qualifications

• Minimum of Bachelor’s Degree in relevant discipline (Business, Science, Medical, Operations, etc.) with 8 years of pharmaceutical industry experience or advanced academic degree with 5 years of pharmaceutical industry experience.
• Minimum of 5 years’ experience in pharmacovigilance. Prior compliance experience within PV is not needed.
• Understanding of GxP requirements is required
• Knowledge of global PV laws and regulations is preferred
• Ability to function in a global matrix environment is preferred
• Excellent communication and writing skills is required
• Ability to lead global work streams, drive teams to make decisions, achieve deliverables and manage and resolve issues independently.
• Understanding of and experience with multi-cultural working is preferred.
• Ability to evaluate processes and procedures against outcomes to identify methods to improve efficiency, accuracy and compliance.
• Ability to utilize appropriate initiative and autonomy in achieving objectives.
• Excellent track record with negotiation and collaboration is required
• Proven experience developing and conducting presentations for different levels of management; ability to tailor presentations to the appropriate level of detail is required 

Primary Location
United States-Pennsylvania-Horsham
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Pharmacovigilance